Study On Safety Of Laparoscopic Total Gastrectomy For Clinical Stage I Gastric Cancer

NCT03007550 | Completed

• 1 other identifier: ZSGC-001
• Study Type: interventional
• Target: 227
• Locations: 1 country
• Sites: 1

Brief Summary

This CLASS02-01 trial is a prospective, multicenter trial for laparoscopic total gastrectomy (LTG) and open total gastrectomy (OTG) in patients with clinical stage I (T1N0M0、T1N1M0、T2N0M0) gastric cancer. The primary purpose of this study is to evaluate the early operative morbidity and mortality and determine the safety of LTG compared with OTG for clinical stage I gastric adenocarcinoma. The second purpose is to evaluate the recovery course and compare the postoperative hospital stay of the patients enrolled in this study.

Conditions

Gastric Cancer

Keywords

Gastric cancer; Laparoscopic total gastrectomy; Open total gastrectomy

Outcome Measures

Primary Outcomes (1)

• Early operative morbidity and mortality rate

  The early operative morbidity and mortality are defined as the event observed within 30 days following surgery, including intraoperative and postoperative complications and/or death.

  30 days

Secondary Outcomes (2)

• Postoperative recovery course

  30 days

• Postoperative hospital stay

  30 days

Study Arms (2)

Laparoscopic total gastrectomy

EXPERIMENTAL

The surgeon will perform LTG with D1+/D2-10 lymphadenectomy for patients enrolled in this group.

Procedure: Laparoscopic total gastrectomy

Open total gastrectomy

OTHER

The surgeon will perform OTG with D1+/D2-10 lymphadenectomy for patients enrolled in this group.

Procedure: Open total gastrectomy

Interventions

Laparoscopic total gastrectomy PROCEDURE

LTG with D1+/D2-10 lymphadenectomy for patients with clinical stage I (T1N0M0、T1N1M0、T2N0M0) gastric adenocarcinoma

Also known as: Study group (LTG)

Laparoscopic total gastrectomy

Open total gastrectomy PROCEDURE

OTG with D1+/D2-10 lymphadenectomy for patients with clinical stage I (T1N0M0、T1N1M0、T2N0M0) gastric adenocarcinoma

Also known as: Control group (OTG)

Open total gastrectomy

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged 18-75 years；
• Primary lesion is pathologically diagnosed as gastric adenocarcinoma, such as papillary adenocarcinoma, tubular adenocarcinoma, mucinous adenocarcinoma, poorly cohesive carcinoma (including signet ring cell carcinoma and other variants), and mixed adenocarcinoma;
• Clinical stage IA (T1N0M0) or IB (T1N1M0, T2N0M0) (According to AJCC-7th TNM staging system);
• Tumor located in the upper or middle third of the stomach, and curative resection is expected to be achievable by total gastrectomy with D1+/D2-10 lymphadenectomy (also apply to multiple primary cancers);
• No invasion to Z-line;
• BMI (Body Mass Index) \< 30 kg/m2;
• No history of upper abdominal surgery (except for laparoscopic cholecystectomy);
• No prior treatment of chemotherapy, radiotherapy, targeted therapy, immunotherapy, etc.;
• No enlargement of splenic hilar lymph nodes;
• Preoperative performance status (ECOG，Eastern Cooperative Oncology Group) of 0 or 1;
• Preoperative ASA (American Society of Anesthesiologists) scoring: I-III;
• Sufficient organ functions;
• Written informed consent.

You may not qualify if:

• Preoperative examinations indicate that the stage of the disease is stage II/III/IV;
• Preoperative examination indicate enlargement of perigastric or retroperitoneal lymph nodes (min diameter≥1.0cm);
• Women during pregnancy or breast-feeding;
• Synchronous or metachronous (within 5 years) malignancies;
• Body temperature ≥ 38℃ before surgery or infectious disease with a systemic therapy indicated;
• Severe mental disease;
• Severe respiratory disease;
• Severe hepatic and renal dysfunction;
• Unstable angina pectoris or history of myocardial infarction within 6 months;
• History of cerebral infarction or cerebral hemorrhage within 6 months;
• Continuous systemic steroid therapy within 1 month (except for topical use);
• Gastric cancer complications (bleeding, perforation, obstruction) that requiring emergency surgery;
• Patients are participating or have participated in another clinical trial (within 6 months).

Sponsors & Collaborators

• Shanghai Zhongshan Hospital: lead

Study Sites (1)

ZhongShan hospital FuDan university

Shanghai, Shanghai Municipality, 200032, China

Location

Related Publications (23)

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MeSH Terms

Conditions

Stomach Neoplasms

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Yihong Sun, MD

  Fudan University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor,Department of General Surgery, Zhongshan Hospital

Study Record Dates

• First Submitted: December 22, 2016
• First Posted: January 2, 2017
• Study Start: January 4, 2017
• Primary Completion: October 24, 2018
• Study Completion: October 24, 2018
• Last Updated: February 20, 2019

Record last verified: 2019-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)